Product Manual

Page 12
5. Warnings and Precautions
• Patients taking Warfarin (Coumadin) and other oral
blood thinners should consult with their healthcare
provider before adjusting their dosage.
• Patients should consult with their doctor for their
appropriate INR therapeutic range.
• Patients who have recently taken or are currently taking
any type of Heparin or Low Molecular Weight Heparin
anticoagulant should not use this test system and should
consult their doctor.
• The system should also not be used to monitor patients
on direct oral anticoagulants (DOACs) including Factor
Xa and Direct Thrombin inhibitors.
Test Site and Blood Sample
• The Coag-Sense PT/INR system is for in vitro diagnostic use only.
• The Coag-Sense meter will not produce a result if the test strip is
past its expiration date.
• The quality of the blood sample can affect PT test results. A blood
sample of poor quality can produce unreliable results. Read the
section on “Collecting a Fingerstick Sample” for more
information.
• Blood samples must be applied to the test strip immediately after
collection or the blood begins to clot, causing unreliable results.
• The blood sample transferred to the test strip must be a minimum
of 10 µL in volume. Low sample volume may cause an error
message.